Ex Parte Aggerholm et al

Patent Trial and Appeal Board

Dec 2, 2015

12964055 (P.T.A.B. Dec. 2, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/964,055 12/09/2010 Steen Aggerholm PA-6744-RFB 4070
9896 7590 12/02/2015
Cook Medical Technologies LLC
P.O. BOX 2269
BLOOMINGTON, IN 47402-2269
EXAMINER
NGUYEN, TUAN VAN
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
12/02/2015 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte STEEN AGGERHOLM,
PER ERIK ELGAARD, and
THOMAS LYSGAARD
________________

Appeal 2013-006563
Application 12/964,055
Technology Center 3700
________________

Before MICHAEL L. HOELTER, MICHELLE R. OSINSKI, and
JASON W. MELVIN, Administrative Patent Judges.

HOELTER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from a final
rejection of claims 1–19, 21, and 22. Final Act. 1 (Office Action Summary).
Claim 20 has been canceled. App. Br. 15 (Claims App.). We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

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THE CLAIMED SUBJECT MATTER
The disclosed subject matter “relates generally to medical devices and
more particularly to angioplasty balloon catheters used to dilate narrowed
portions of a lumen such as by cutting or scoring balloons.” Spec. 1:14–16.
Independent claim 1 is reproduced below and is illustrative of the claims on
appeal:
1. A scoring balloon raw material form for an angioplasty
balloon catheter including a balloon wall, and one or more scoring
elements formed integrally with the balloon wall; wherein the balloon
wall includes at least one zone of greater thickness adjacent the or
each scoring element, the at least one zone of greater thickness
extending radially in the region of 10% to 20% of the overall
circumference of the raw material form.
App. Br. 12 (Claims App.).

REFERENCE RELIED ON BY THE EXAMINER
Sirhan US 2003/0144683 A1 July 31, 2003
THE REJECTION ON APPEAL
Claims 119, 21, and 22 rejected under 35 U.S.C. § 103(a) as
unpatentable over Sirhan.
ANALYSIS
Independent claim 1 recites a “raw material form” having a “balloon
wall [that] includes at least one zone of greater thickness adjacent the or
each scoring element.” Claim 1 further recites that this zone of greater
thickness of the balloon wall extends “in the region of 10% to 20% of the
overall circumference of the raw material form.” Independent claim 11
includes similar language regarding a “balloon wall . . . formed with at least
one zone of greater thickness adjacent the or each scoring element,” but
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instead specifies this zone as “extending in an arc in the range of 10° to
60°.” App. Br. 1314 (Claims App.). Independent claim 22 is similar but
recites the zone “extending in an arc in the range of 30° to 40°.” App. Br. 15
(Claims App.).
The Examiner provides an annotation of Figure 5 of Sirhan which is
used by the Examiner to identify item 37. Ans. 4. The Examiner finds that
this figure discloses “two zones of greater wall thickness positioned on
either side [of the] scoring element (each zone is designated by reference
number 37 shown in Fig. 5.” Final Act. 3. The Examiner’s annotated
Figure 5 of Sirhan is replicated below:

Figure 5 is a sectional view of an inflatable balloon showing wing 34.
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The Examiner acknowledges that “Sirhan discloses the invention
substantially as claimed except for disclosing [the] dimensions of base 37”
being within the claimed ranges. Final Act. 4 (citing claims 1, 2, 6, 11, 12,
and 22). On this point, the Examiner references Sirhan’s teaching that:
[t]he wings 34 may be present in any number, and may be of
any size, or form any suitable angle with a base 37 formed with
reference to the outer surface of the balloon in an expanded
configuration, as may be necessary to properly perform an
intended procedure.
Sirhan ¶ 26. Based on this disclosure, the Examiner states that “one of
ordinary skill in the art would recognize that dimensions of the base 37 are
dependent on the height, the angle and the width of the wing 34.” Final Act.
4. As such, the Examiner states that “[t]hese variables of the wing are the
effective variables to make the device of Sirhan to properly perform an
intended procedure.” Final Act. 4. The Examiner thus concludes that it
would have been obvious “to design the wings 34 of Sirhan so that the two
zones of the greater thickness regions 37 would have the dimensions as
required in claims 1, 2, 6, 11, 12 and 22” and that “discovering the optimum
or workable ranges involves only routine skill in the art.” Final Act. 4
referencing In re Aller, 220 F.2d 454, 456 (CCPA 1955).
On the one hand, it is apparent that the Examiner is correlating
Sirhan’s base 37 with the claimed zone of greater thickness adjacent the
scoring element. Final Act. 3. On the other hand, Appellants “contend the
filet structure [identified by the Examiner as zones 37 in Figure 5] does not
actually exist in Sirhan” because “Sirhan’s specification does not mention a
filet.” App. Br. 6. Appellants also argue that “the curved portion at the
intersection of the wing and the balloon wall are merely the result of artistic
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license taken by the draftsman and not the manufacturing process.” App. Br.
7.
Regarding Appellants’ contentions, our reviewing court has held that
drawings can be used as prior art, without referring to the surrounding
description, only if the prior art features are clearly disclosed by the
drawing. See, e.g., In re Wagner, 63 F.2d 987, 986–87 (CCPA 1933). Here,
the filets, which transition between Sirhan’s scoring element (or wing) and
balloon wall, are clearly disclosed. See also In re Mraz, 455 F.2d 1069,
1072 (CCPA 1972) (“[W]e did not mean that things patent drawings show
clearly are to be disregarded.”); In re Seid, 161 F.2d 229, 231 (CCPA 1947)
(“[A]n accidental disclosure, if clearly made in a drawing, is available as a
reference.”) (citations omitted). Accordingly, we are not persuaded by
Appellants’ contentions that the described filet does not exist or is merely
the result of artistic license. Instead, the Examiner can properly rely on
Sirhan’s disclosure of the curved filet adjacent the scoring element.
However, as previously indicated, the Examiner is correlating
Sirhan’s base 37 with the claimed zone of greater thickness. Final Act. 3.
Sirhan’s base 37 is described as connected with wing 34 and “formed with
reference to the outer surface of the balloon,” but not with any separate
parameters such as curvature of the filets that comprise base 37. Sirhan
¶ 26. Even the Examiner’s annotated drawing (see supra) positions wing 34
on one side of the transition point and the filet on the other. While Sirhan
clearly discloses a filet, the greater wall thickness associated with the filet
appears to cease at the end of the filet. In other words, Sirhan does not
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appear to disclose any continuation of a greater wall thickness beyond the
end of the filet.1
Although the dimensions of wing 34 (and in some fashion the
dimension of base 37) may vary as expressed in Sirhan (see supra), there is
no indication that any wing (or base) variation will result in a corresponding
change in the curvature of the base filet shown in Figure 5 of Sirhan. Hence,
we are not in agreement with the Examiner that Sirhan teaches base 37 as
having a variable that affects the illustrated filet. See Final Act. 4. We
instead agree with Appellants that “[t]he measurements of the zone are not
related to the height, angle, and width of the wing, as those dimensions do
not properly describe the zone of thickness.”2 App. Br. 7. As such, we also
agree with Appellants that “Aller cannot be applied to Sirhan and
Applicants’ invention” in an attempt to ascertain the claimed ranges via
optimization of a result effective variable. App. Br. 8; see also Reply Br. 4.
This is because “Sirhan discloses no general measurements as to the
thickness of the balloon wall or the distance that zone extends beyond the
wings.” App. Br. 9.
The Examiner’s Answer also provides a rationale as to why one
skilled in the art might be motivated to construct Sirhan’s device with

1 Appellants’ Specification indicates that the greater wall thickness is
“measured at the transition point between the balloon wall and the cutting or
scoring element, identified as point or zone 27 in Figure 3.” Spec. 11:813.
Hence, when measuring from the described transition point, Sirhan’s
disclosed filet would be included in such measurement.
2 Appellants also state that “the zone of thickness is measured by how far it
extends beyond the wing and the thickness of the wall, the zone of thickness
cannot be defined by reference to the height, width and angle of the wing as
described in Sirhan.” App. Br. 8.
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“additional material at the intersection point between the scoring element
and the balloon wall (zone of greater thickness) to suit an intended
procedure.” Ans. 6; see also Sirhan ¶ 26. To be specific, the Examiner
states that one skilled in the art “would recognize that for stenosis with hard
plaque, the width of the base and the additional material at the intersection
point between the scoring element and the balloon wall (zone of greater
thickness) as disclosed by Sirhan should be made wider and thicker to
provide a better force concentration in order to cut the hard plaque.” Ans. 6
see also id. at 7–9. As such, any additional material or modification is
understood to be directed to the filet, and not with respect to any balloon
wall beyond the filet. Without an explanation, the addition of material
beyond Sirhan’s filet is indicative of improper hindsight analysis. See App.
Br. 10. The Supreme Court has warned that the “factfinder should be aware
. . . of the distortion caused by hindsight bias and must be cautious of
arguments reliant upon ex post reasoning.” KSR Int'l Co. v. Teleflex Inc.,
550 U.S. 398, 421 (2007).
In summary, while it is clearly known to use a scoring element and a
transitional filet of indeterminate shape, we are not persuaded that it would
have been obvious in view of Sirhan to provide additional material to the
balloon wall beyond the filet; or to provide additional material beyond the
filet so as to form a zone of greater thickness that is adjacent the scoring
element and that extends a certain percentage of the overall circumference or
in an arc in a certain percentage range. Further, lacking a result effective
variable that might alter a measure from the identified “transition point”
(Ans. 4; Spec. 11:813), the Examiner does not explain how discovering the
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optimum or workable range of this measure (i.e., the claimed ranges)
“involves only routine skill in the art” (Final Act. 4).
We reverse the Examiner’s rejection of claims 1–19, 21, and 22.
DECISION
The Examiner’s rejection of claims 119, 21, and 22 is reversed.

REVERSED

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